Status:
COMPLETED
Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
This study evaluated the effects of tamoxifen exposure in combination with vorinostat on viral reactivation among HIV-1 infected post-menopausal women with virologic suppression on antiretroviral ther...
Detailed Description
The selective estrogen receptor modulator (SERM) tamoxifen may enhance the ability of the histone deacetylase inhibitor (HDACi) vorinostat to reverse HIV-1 latency. This study evaluated the safety of ...
Eligibility Criteria
Inclusion
- HIV-1 infection
- Postmenopausal at study entry with agreement not to participate in assisted reproductive technology in the future.
- CD4+ cell count greater than 300 cells/uL obtained within 90 days prior to study entry.
- Continuous antiretroviral therapy (ART) for at least 2 years prior to enrollment with no known interruption in therapy for greater than 7 days within 90 days prior to study entry.
- Plasma HIV-1 RNA level of less than 20 copies/mL obtained by Roche HIV-1 viral load assay or less than 40 copies/mL obtained by the Abbott assay, within 90 days prior to study entry.
- Ability and willingness of potential participant to provide written informed consent.
Exclusion
- History of venous thromboembolism.
- History of stroke.
- Known history of hypercoagulable state.
- Tobacco smoking or e-cigarette use within 90 days prior to study entry.
- History of any malignancy requiring systemic chemotherapy or systemic immunotherapy.
- History of endometrial or breast cancer or known genetic testing with BRCA positive results indicating an increased risk for breast and ovarian cancer.
- Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, or investigational therapy within 60 days prior to study entry.
- Any systemic hormonal therapy defined as oral or injectable contraceptives, estrogen and combined estrogen-progesterone replacement therapy in the prior 12 months, or a hormone containing intrauterine device (IUD) within 6 months prior to study entry.
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.
Key Trial Info
Start Date :
April 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03382834
Start Date
April 26 2018
End Date
July 27 2023
Last Update
July 3 2024
Active Locations (15)
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1
Alabama CRS
Birmingham, Alabama, United States, 35294
2
UCLA CARE Center CRS
Los Angeles, California, United States, 90035
3
Ucsf Hiv/Aids Crs
San Francisco, California, United States, 94110
4
Harbor-UCLA CRS
Torrance, California, United States, 90502